ID
41531
Descripción
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma
Palabras clave
Versiones (2)
- 23/9/20 23/9/20 -
- 2/11/20 2/11/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
2 de noviembre de 2020
DOI
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Licencia
Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162
Non-Serious Adverse Events; Study Conclusion (Report Final and Annex Report 2 Final)
Descripción
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Descripción
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Descripción
AE No.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Descripción
Non-Serious Adverse Event Description
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Descripción
Non-Serious Adverse Event site
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1515974
Descripción
Please check in case of new onsets of autoimmune diseases or immune-mediated inflammatory disorders
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0004364
- UMLS CUI [1,2]
- C0746890
- UMLS CUI [2,1]
- C0012634
- UMLS CUI [2,2]
- C4330477
Descripción
Non-Serious Adverse Event Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Descripción
Non-Serious Adverse Event Start Date during immediate post-administration period (30 minutes)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C3469597
- UMLS CUI [2,2]
- C0687676
- UMLS CUI [2,3]
- C0347984
Descripción
Non-Serious Adverse Event Date stopped
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Descripción
(CTC AE GRADING)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Descripción
Relationship to investigational products
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descripción
Non-Serious Adverse Event Outcome:
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Descripción
Death Form
Alias
- UMLS CUI-1
- C0011065
- UMLS CUI-2
- C1516308
Descripción
Did the patient die during the study?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Descripción
Date of death
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
Was an autopsy performed?
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0004398
Descripción
(tick only one box)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0007465
Descripción
Specify comorbidity
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C2348235
Descripción
Other cause of death, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Descripción
Study Conclusion - Pregnancy Information
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0032961
- UMLS CUI-4
- C1533716
Descripción
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Descripción
Was the patient withdrawn from the study?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0422727
Descripción
(tick one box only)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Descripción
Specify SAE No.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Descripción
Specify AE No.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Descripción
Specify protocol viaolation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Descripción
Specify other reason for withdrawal
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [2]
- C2348235
Descripción
Who made the decision
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0679006
Descripción
Date of last contact:
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0805839
Descripción
No → Please give details in Adverse Events section
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Descripción
Study Conclusion - Investigator's Siganture
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C2346576
- UMLS CUI-4
- C0011008
Descripción
I confirm that I have reviewed the data in this Case Report Form for this patient. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator's Siganture Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Printed Investigator's name:
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Non-Serious Adverse Events; Study Conclusion (Report Final and Annex Report 2 Final)
C2348563 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
C0746890 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C4330477 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C3469597 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0008972 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
C0392360 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0681850 (UMLS CUI [1,2])
C0008972 (UMLS CUI-2)
C2346576 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
C0011008 (UMLS CUI [1,2])